Friday, March 20, 2009

The State-Of-The-Art Defense In Drug/Device Cases After Levine

A linchpin of the preemption analysis in Wyeth v. Levine, 2009 WL 529172 (U.S. March 4, 2009), was the Court’s discussion of the “changes being effected” regulation, id. at *7-8, which in turn depended on the existence of either “newly acquired information” or “new analyses of previously submitted data.” Id. at *7. Factually, there wasn’t much of a record, so the Court held, essentially, that the defendant hadn’t proven the negative – that an analysis of twenty “incidents” (we’d guess adverse drug experience reports, but the opinion doesn’t specify) wouldn’t have yielded “new” information upon which a CBE submission could have been based. Id. at *8 (“[defendant] could have analyzed the accumulating data and added a stronger warning”).

To us, all this emphasis on “newness” suggests the likelihood that state-of-the-art issues will see increased play in prescription drug product liability litigation after Levine. Since we’ve been blogging, the state-of-the-art defense in prescription drug litigation hasn’t been all that hot of a topic. In terms of recent cases, there’s been the Maryland high court decision in Gourdine v. Crews, 955 A.2d 769, 781 (Md. 2008), which discussed state-of-the-art issues as a reason for deciding that negligence and strict liability weren’t all that different, and the trial court decision in Totterdale v. Lederle Laboratories, 2008 WL 972657 (W. Va. Cir. March 19, 2008), which rejected some sort of weird duty to develop a safer design more quickly than the state of the art actually advanced. In short, not a whole lot on the subject recently.

That’s likely to change, so we thought we’d stay ahead of the curve and provide our readers with the lay of the land. The state-of-the-art defense isn’t a hard one to understand. It’s the rather self-evident proposition that a defendant shouldn’t be liable for not warning about something (usually, but not necessarily, a product risk) that hasn’t been discovered or invented yet. That’s straightforward enough, and as long as product liability cases were brought under the “reasonable man” standard of negligence, there wasn’t any significant dispute over this requirement. It wasn’t “reasonable” to expect a defendant to know the unknowable.

With the advent of strict liability, things changed, and there was a good deal of agitation – at least on the academic front – that strict liability wasn’t really “strict” if defendants could escape liability because science hadn’t yet discovered the causal link that the plaintiff was asserting. Some courts bought the argument in some circumstances, most frequently in asbestos cases. Where such rulings were broad enough, they tended to create legislative backlash, as happened in New Jersey. See N.J.S.A. 2A:58C-3a(1) (“state of the art” a complete defense).

Drugs have always been treated more carefully by the law than things that go clank, and courts have been very leery of tinkering with the state-of-the-art defense in a field so dependent upon advances in scientific knowledge as prescription drugs. State of the art was the issue that prompted the California Supreme Court essentially to exempt prescription drugs from strict liability in Brown v. Superior Court, 751 P.2d 470 (1988):

Thus far the courts have tended to hold the manufacturer to a high standard of care in preparing and testing drugs of unknown potentiality and in giving warning; but in the absence of evidence that this standard has not been met, they have refused to hold the maker liable for unforeseeable harm.
Id. at 479 (reaffirming state-of-the-art defense in design defect context).

For these same reasons of policy, we reject plaintiff’s assertion that a drug manufacturer should be held strictly liable for failure to warn of risks inherent in a drug even though it neither knew nor could have known by the application of scientific knowledge available at the time of distribution that the drug could produce the undesirable side effects suffered by the plaintiff.

Id. at 480.

There are lots of rationales for why drug companies (and device and vaccine makers, too) shouldn’t be liable for not warning about scientifically unknown risks or not using some design that hasn’t been invented yet. The Illinois Supreme Court, years ago, summed them up well: to “hold the manufacturer liable for failure to warn of a danger of which it would be impossible to know based on the present state of human knowledge would make the manufacturer the virtual insurer of the product.” Woodill v. Parke Davis & Co., 402 N.E.2d 194, 199 (Ill. 1980). A manufacturer is not required to be “clairvoyant,” but rather, its judgments are evaluated “as of the time the product is distributed to the plaintiff.” Toner v. Lederle Laboratories, 732 P.2d 297, 306 (Idaho 1987).

The thin judicial support for a hindsight approach to the duty to warn is easily explained. The goal of the law is to induce conduct that is capable of being performed. This goal is not advanced by imposing liability for failure to warn of risks that were not capable of being known.

Vassallo v. Baxter Healthcare Corp., 696 N.E.2d 909, 922-23 (Mass. 1998).

For all of these reasons, we believe that the state-of-the-art defense dovetails with the Supreme Court’s evaluation of the prerequisites for a CBE submission in Levine. If, at the relevant time, the warning in question would not have supported common-law liability under the state-of-the-art defense, then there’s no factual basis for a CBE submission under the relevant FDA regulation. Where a CBE submission is not possible under the facts, then that’s one route to the “clear evidence that the FDA would not have approved a [label] change” that Levine, 2009 WL 529172, at *9, stated would support preemption. The state of the art defense cases thus provide a well-established body of law, and a reasonably numerous collection of factual analogies for dealing with the knotty question of whether there was insufficient “new” information for the FDA to allow a CBE submission, and thus for the application of preemption.

Here are the state-of-the-art cases that we’re familiar with in our limited field of drug and medical device product liability litigation:

Alaska: Shanks v. Upjohn Co., 835 P.2d 1189, 1200 (Alaska 1992); Polley v. Ciba-Geigy Corp., 658 F.Supp. 420, 421 (D. Alaska 1987).

Arizona: Gaston v. Hunter, 588 P.2d 326, 340 (Ariz. App. 1978).

Arkansas: DeLuryea v. Winthrop Laboratories, 697 F.2d 222, 229 (8th Cir. 1983).

California: Carlin v. Superior Court, 920 P.2d 1347, 1350-51 (Cal. 1996); Brown v. Superior Court, 751 P.2d 470, 480-81 (Cal. 1988); Valentine v. Baxter Healthcare Corp., 81 Cal. Rptr.2d 252, 263 (Cal. App. 1999); Rosburg v. Minnesota Mining & Manufacturing Co., 226 Cal. Rptr. 299, 305-06 (Cal. App. 1986); Fogo v. Cutter Laboratories, Inc., 137 Cal. Rptr. 417, 422-23 (Cal. App. 1977); Carmichael v. Reitz, 95 Cal. Rptr. 381, 404 (Cal. App. 1971); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 2023569, at *2 (D. Minn. July 6, 2007).

Colorado: Belle Bonfils Memorial Blood Bank v. Hansen, 665 P.2d 118, 123 (Colo. 1983).

Connecticut: Vitanza v. Upjohn Co., 778 A.2d 829, 836 (Conn. 2001); Tomer v. America Home Products Corp., 368 A.2d 35, 38 (Conn. 1976); LaMontagne v. E.I. Du Pont De Nemours & Co., 41 F.3d 846, 859 (2d Cir. 1994); Basko v. Sterling Drug, Inc., 416 F.2d 417, 426 (2d Cir. 1969).

District of Columbia: McNeil Pharmaceutical v. Hawkins, 686 A.2d 567, 578 (D.C. 1996).

Florida: E.R. Squibb & Sons, Inc. v. Farnes, 697 So.2d 825, 828 (Fla. 1997); Bailey v. Janssen Pharmaceutica, Inc., 2006 WL 3665417, at *4 (S.D. Fla. Nov. 14. 2006).

Hawaii: Ontai v. Straub Clinic & Hospital, Inc., 659 P.2d 734, 743 (Haw. 1983).

Idaho: Toner v. Lederle Laboratories, 732 P.2d 297, 306-07 (Idaho 1987).

Illinois: Martin v. Ortho Pharmaceutical Corp., 661 N.E.2d 352, 354 (Ill. 1996); Woodill v. Parke Davis & Co., 402 N.E.2d 194, 198-99 (Ill. 1980); Needham v. White Laboratories, Inc., 847 F.2d 355, 357-58 (7th Cir. 1988); McMahon v. Eli Lilly & Co., 774 F.2d 830, 835 (7th Cir. 1985); Martinkovic v. Wyeth Laboratories, Inc., 669 F.Supp. 212, 215 (N.D. Ill. 1987).

Indiana: Ortho Pharmaceutical Corporation v. Chapman, 388 N.E.2d 541, 548 (Ind. App. 1979); Phelps v. Sherwood Medical Industries, 836 F.2d 296, 305-06 (7th Cir. 1987).

Iowa: Moore v. Vanderloo, 386 N.W.2d 108, 116 (Iowa 1986); Brazzell v. United States, 880 F.2d 84, 86-87 (8th Cir. 1989).

Kansas: Savina v. Sterling Drug, Inc., 795 P.2d 915, 926-27 (Kan. 1990); Tetuan v. A.H. Robins Co., 738 P.2d 1210, 1227 (Kan. 1987); Wooderson v. Ortho Pharmaceutical Corp., 681 P.2d 1038, 1057, 1062-64 (Kan. 1984).

Louisiana: La.Rev. Stat. Ann. §9:2800.59(B); Cauvin v. Sisters of Mercy Health System, Inc., 818 So.2d 833, 835 (La. App. 2002); Kinney v. Hutchinson, 468 So.2d 714, 718 (La. App. 1985); Miller v. Upjohn Co., 465 So.2d 42, 45 (La. App. 1985); Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254, 272 n.11 (5th Cir. 2002); Williams v. Ciba-Geigy Corp., 686 F.Supp. 573, 575 (W.D. La. 1988), aff’d, 864 F.2d 789 (5th Cir. 1988).

Maine: Porter v. Pfizer Hospital Products Group, Inc., 783 F.Supp. 1466, 1475 (D. Me. 1992).

Maryland: Gourdine v. Crews, 955 A.2d 769, 781 (Md. 2008); Miles Laboratories, Inc. v. Doe, 556 A.2d 1107, 1121-22 (Md. 1989); Doe v. Miles Laboratories, Inc., 927 F.2d 187, 191-93 (4th Cir.1991); Chambers v. G.D. Searle & Co., 441 F.Supp. 377, 381-82 (D. Md. 1975), aff’d, 567 F.2d 269 (4th Cir. 1977).

Massachusetts: Vassallo v. Baxter Healthcare Corp., 696 N.E.2d 909, 923-24 (Mass. 1998); Kelly v. Wyeth, 2007 WL 1302589, at *7 (Mass. Super. April 12, 2007); Haidak v. Pfizer, Inc., 2002 WL 126680, at *2 (S.D.N.Y. Jan. 31, 2002).

Michigan: Muilenberg v. Upjohn Co., 426 N.W.2d 767, 773 (Mich. App. 1988); May v. Parke, Davis & Co., 370 N.W.2d 371, 376 (Mich. App. 1985); Dunn v. Lederle Laboratories, 328 N.W.2d 576, 580 (Mich. App. 1983).

Minnesota: O’Hare v. Merck & Co., 381 F.2d 286, 291 (8th Cir. 1967).

Missouri: Bine v. Sterling Drug, Inc., 422 S.W.2d 623, 627-28 (Mo. 1968); Meyer v. Astrazeneca Pharmaceuticals, L.P., 224 S.W.3d 106, 108 (Mo. App. 2007); Johnston v. Upjohn Co., 442 S.W.2d 93, 97 (Mo. App. 1969); Sterling Drug, Inc. v. Cornish, 370 F.2d 82, 84 (8th Cir. 1966); Stanger v. Smith & Nephew, Inc., 401 F.Supp.2d 974, 980-81 (E.D. Mo. 2005).

Montana: Hill v. Squibb & Sons, 592 P.2d 1383, 1388 (Mont. 1979); Davis v. Wyeth Laboratories, Inc., 399 F.2d 121, 129 (9th Cir. 1968).

New Hampshire: Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652, 657-58 (1st Cir. 1981).

New Jersey: N.J.S.A. 2A:58C-3a(1); Feldman v. Lederle Laboratories, 479 A.2d 374, 386-87 (N.J. 1984); Ferrigno v. Eli Lilly & Co., 420 A.2d 1305, 1321 (N.J. Super. Law Div. 1980).

New Mexico: Richards v. Upjohn Co., 625 P.2d 1192, 1195-96 (N.M. App. 1980).

New York: Mulhall v. Hannafin, 841 N.Y.S.2d 282, 285-86 (N.Y.A.D. 2007); Donigi v. American Cyanamid Co., 394 N.Y.S.2d 422, 422-23 (N.Y.A.D. 1977), aff’d mem., 374 N.E.2d 1245 (N.Y. 1978); Friedman v. Medtronic, Inc., 345 N.Y.S.2d 637, 642 (N.Y.A.D. 1973); Garfinkel v. Bayer Corp., 2003 WL 25668274 (N.Y. Sup. Oct. 30, 2003); Tenuto v. Lederle Laboratories, 695 N.Y.S.2d 259, 263 (N.Y. Sup. 1999), aff’d, 714 N.Y.S.2d 448 (N.Y.A.D. 2000).

North Dakota: Harris v. McNeil Pharmaceutical, 2000 WL 33339657, at *3 n.2 (D.N.D. Sept. 5, 2000).

Ohio: White v. Wyeth Laboratories, Inc., 533 N.E.2d 748, 753 (Ohio 1988); see Ohio Rev. Code §2307.76(A0(1)(a).

Oklahoma: Edwards v. Basel Pharmaceuticals, 933 P.2d 298, 303 (Okla. 1997).

Oregon: McEwen v. Ortho Pharmaceutical Corp., 528 P.2d 522, 528-29 (Or. 1974); Cochran v. Brooke, 409 P.2d 904, 907 (Or. 1966).

Pennsylvania: Hahn v. Richter, 628 A.2d 860, 867-68 (Pa. Super. 1993), aff’d, 673 A.2d 860 (Pa. 1996); Leibowitz v. Ortho Pharmaceutical Corp., 307 A.2d 449, 458 (Pa. Super. 1973); Mazur v. Merck & Co., 964 F.2d 1348, 1366-67 (3d Cir. 1992); In re Zyprexa Products Liability Litigation, 489 F.Supp.2d 230, 268 (E.D.N.Y. 2007).

Puerto Rico: Muniz-Nunez v. American Home Products Corp., 582 F.Supp. 459, 462 (D.P.R. 1984).

Rhode Island: Castrignano v. E.R. Squibb & Sons, Inc., 546 A.2d 775, 782 (R.I. 1988); Castrignano v. E.R. Squibb & Sons, Inc., 900 F.2d 455, 459-60 (1st Cir. 1990).

South Dakota: McElhaney v. Eli Lilly & Co., 575 F.Supp. 228, 231-32 (D.S.D. 1983), aff’d, 739 F.2d 340 (8th Cir. 1984).

Tennessee: Witherspoon v. Ciba-Geigy Corp., 1986 WL 2138, at *3 (Tenn. App. Feb. 12, 1986).

Texas: Bristol-Myers Co. v. Gonzales, 561 S.W.2d 801, 804 (Tex. 1978); Crocker v. Winthrop Laboratories, 514 S.W.2d 429, 433 (Tex. 1974); Gerber v. Hoffmann-La Roche Inc., 392 F.Supp.2d 907, 915 (S.D. Tex. 2005).

Utah: Grundberg v. Upjohn Co., 813 P.2d 89, 98 (Utah 1991).

Virginia: Stanback v. Parke, Davis & Co., 502 F.Supp. 767, 770 (W.D. Va. 1980).

Washington: Laisure-Radke v. Par Pharmaceutical, Inc., 426 F.Supp.2d 1163, 1172-73 (W.D. Wash. 2006).

West Virginia: Totterdale v. Lederle Laboratories, 2008 WL 972657 (W. Va. Cir. March 19, 2008).

Wisconsin: Stupak v. Hoffman-La Roche, Inc., 2007 WL 4218982, at *2 (M.D. Fla. Nov. 29, 2007).

Wyoming: Thom v. Bristol-Myers Squibb Co., 353 F.3d 848, 854-55 (10th Cir. 2003); Jacobs v. Dista Products Co., 693 F.Supp. 1029, 1033-34 (D. Wyo. 1988)

We’ll be greatly interested to see how the state-of-the-art defense evolves in prescription drug product liability litigation, now that the Supreme Court has invoked knowability/unknowability principles as a limitation on preemption.

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